Telehealth vs In-Person Therapy for Parkinson's Dysphagia
Rehabilitation of Airway Protection in Parkinson's Disease
Recruiting
Phase 2Interventional Study
Parkinson DiseaseDysphagia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 – 90
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Teachers College, Columbia University · Other
Who this trial is looking for
This trial is looking for people with Parkinson's Disease who have trouble swallowing. Participants will receive either in-person or remote therapy to help improve their ability to protect their airways while swallowing.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with Parkinson's Disease.
I have swallowing difficulties.
I am between the ages of 50 and 90.
I am not currently receiving exercise-based swallowing therapy.
You may not be able to join if
I have another neurological disorder.
I have a history of head or neck cancer.
I have breathing disorders or diseases.
I have smoked in the past five years.
I have uncontrolled high blood pressure.
I have severe depression or dementia.
I am allergic to capsaicin or barium.
I live more than 1.5 hours away from the study locations.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm deli…
Airway protective disorders are a prevalent and progressive consequence of Parkinson's Disease (PD), and often result in aspiration pneumonia which is the leading cause of death in PD. Despite this, a large number of patients with PD do not access specialized services to address these critical deficits. The investigators will examine the comparative effectiveness of a novel treatment paradigm delivered in-person versus via telehealth in persons with PD, as well as the role of patient burden and treatment adherence on outcomes; thus, the proposed research is relevant to public health and in line with NIH's mission to identify novel, efficacious, and accessible rehabilitation strategies for short- and long-term improvement of dysfunctional airway protection in PD.
Trial Locations
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Status
Eligibility Criteria
Inclusion criteria:
* Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using …
Inclusion criteria:
* Diagnosed with PD (Hoehn and Yahr Stages II-IV)126,127 confirmed by a Movement Disorders fellowship trained neurologist having reviewed the video recorded Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assessment for each participant and using strict UK brain bank criteria
* airway protective deficits as defined as a minimum of penetration of thin liquids (penetration-aspiration score\>3) as determined by instrumental swallowing assessment and/or dystussia as determined by voluntary cough assessment (PEFR ≤4.1 L/s)
* not actively receiving exercise-based swallowing therapy
* between the ages of 50 and 90.
Exclusion criteria:
* Other neurological disorders (e.g., multiple sclerosis, stroke, brain tumor, etc.)
* history of head and neck cancer
* history of breathing disorders or diseases (e.g., COPD)
* history of smoking in the last five years
* uncontrolled hypertension
* difficulty complying due to neuropsychological dysfunction (i.e., severe depression with \>28 on the Beck Depression Index (BDI-II), dementia with \<19 on the Montreal Cognitive Assessment (MoCA))
* allergy to capsaicin or barium
* further than 1.5 hours (door to door) distance from either Teachers College, Columbia University or Purdue University.
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